UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044142 |
|---|---|
| Receipt number | R000050405 |
| Scientific Title | A single-center prospective observational study to evaluate the usefulness of endoscopic diagnosis of superficial carcinoma of the head and neck using the GIF-1200N ultra-thin upper gastrointestinal endoscope and ENT endoscope |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2023/05/09 09:24:24 |
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Basic information
Public title
A single-center prospective observational study to evaluate the usefulness of endoscopic diagnosis of superficial carcinoma of the head and neck using the GIF-1200N ultra-thin upper gastrointestinal endoscope and ENT endoscope
Acronym
An observational study of superficial carcinoma of the head and neck using an ultra-thin endoscope
Scientific Title
A single-center prospective observational study to evaluate the usefulness of endoscopic diagnosis of superficial carcinoma of the head and neck using the GIF-1200N ultra-thin upper gastrointestinal endoscope and ENT endoscope
Scientific Title:Acronym
An observational study of superficial carcinoma of the head and neck using an ultra-thin endoscope
Region
| Japan |
Condition
Condition
Superficial carcinoma of the Head and Neck
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of observation for superficial head and neck cancer using upper gastrointestinal endoscopy and otorhinolaryngological endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visibility of abnormal vessels and demarcation line of the lesion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
ultra-thin upper gastrointestinal endoscope
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with superficial carcinoma of the head and neck who undergo oral surgery
Key exclusion criteria
Patients determined to be ineligible
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Chikatoshi |
| Middle name | |
| Last name | Katada |
Organization
Kitasato University School of Medicine
Division name
Gastroenterology
Zip code
252-0374
Address
Kanagawa
TEL
0427788111
ckatada@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Kano |
Organization
Kitasato University School of Medicine
Division name
Otorhinolaryngology- Head and Neck Surgery
Zip code
252-0374
Address
Kanagawa
TEL
0427788111
Homepage URL
kkent@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato university
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Kitasato University school of medicine - Hospital
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
0427788111
rinrib@med.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 07 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050405
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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